Who are Maven E&L Ltd ?
Maven E&L Ltd is a business created to serve the pharmaceutical and medical industry with expert consultancy in a topic area which continues to grow in regulatory significance for Pharma namely the study of Extractables and Leachables (E&L)
There is no one published or agreed process for study of E&L to meet regulatory expectations.
I have been involved in this topic area since industry and regulators first began to highlight this challenging area, which can affect both safety and quality of a wide range pharmaceutical products and dose form.
Managing Director & Principal Consultant
Maven E&L Ltd
I am an Analytical Chemist by training, for over 20 years I have directed scientific study and created regulatory documentation to meet the ongoing regulatory requirements in extractables and leachables (E&L).
I have written or overseen 20+ regulatory submissions sections in the topic area of E&L. These include a wide variety of different dose forms and regulators.
These submissions contributed to the 1st time approval of many products including MDIs, DPIs, ANS, Topicals, Biopharmaceutical and Small molecule Parenterals, plus the 1st approved Gene Therapy product for ADA-SCID - Strimvelis.
I established a single internal systematic approach to extractable and leachable testing for a multi-national pharmaceutical company, introducing a technical risk assessment process and template, using a bespoke Failure Mode Effects Analysis (FMEA) process.
This approach, which is closely aligned to ICH Q9 (Quality risk management) provides documented justification for testing then undertaking (extractable tests or leachable ) saving time and money by focusing only on activity which is scientifically justified. This approach formed the basis of the company's international policy document.
I have developed and delivered training seminar on science led risk based approaches to E&L
I regularly present and chair sessions at international conferences on the topic of E&L
Let my experience bring Expert Consultancy to your next project